FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LIQUICHEK IMMUNOASSAY PLUS CONTROL, MODEL 360, 361, 362, 363
K Number: K001373
·
Decision May 25, 2000
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
672
Applicant Total
319
Review Days
24
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Basic Information
- Device Name
- LIQUICHEK IMMUNOASSAY PLUS CONTROL, MODEL 360, 361, 362, 363
- K Number
- K001373
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bio-Rad
- Date Received
- May 1, 2000
- Decision Date
- May 25, 2000
- Product Code
- JJY
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | FDA class 1 | Clinical Chemistry |
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